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ARTICLE IN BRIEF

Acupuncture appears to reduce headache frequency among patients with episodic migraine more than usual care or sham acupuncture, according to a Cochrane review of 22 trials with 4,985 participants reported in the October 18 Annals of Internal Medicine.

Acupuncture reduced headache frequency more than prophylactic drugs after treatment but not at the six-month follow-up, the report also found.

“Our findings about the number of days with migraine per month can be summarized as follows — if people have six days with migraine per month on average before starting treatment, this would be reduced to five days in people receiving only usual care, to four days in those receiving fake acupuncture or a prophylactic drug, and to three and a half days in those receiving true acupuncture,” co-author Klaus Linde, MD, deputy director of the Centre for Complementary Medicine Research at the Technical University of Munich in Germany, told Neurology Today.

STUDY PROTOCOLS

Dr. Linde and colleagues looked at 22 trials that compared acupuncture with usual care, sham interventions, or prophylactic drugs in patients who had at least one year of episodic migraine. Five randomized controlled trials (RCTs) treated all patients at the same acupuncture points, seven RCTs had semi-standardized treatments, and 10 RCTs allowed individualization of acupuncture points.

In 15 trials, acupuncture was compared with sham acupuncture. The frequency of headaches was cut in half in 50 percent of patients receiving true acupuncture, compared with 41 percent people receiving sham acupuncture.

“The results were dominated by three good quality large trials (with about 1,200 people) showing that the effect of true acupuncture was still present after six months,” Dr. Linde said. “There were no differences in the number of side effects of real and sham acupuncture, or the numbers dropping out because of side effects.”

In five trials, acupuncture was compared to a prophylactic drug treatment, but only three trials provided information for analysis. At three months, headache frequency halved in 57 percent of patients receiving acupuncture, compared with 46 percent taking prophylactic drugs. After six months, headache frequency halved in 59 percent of patients receiving acupuncture, compared with 54 percent of people taking the drug. People receiving acupuncture reported side effects less often than people receiving drugs, and were less likely to drop out of the trial.

“Our review adds to the accumulating evidence that acupuncture seems to be effective in chronic pain conditions,” Dr. Linde said. “As for other pain conditions, the exact location seems to have a role, but the effect over sham acupuncture is small.”

However, the difference between sham acupuncture and no treatment is quite large, he noted. “This suggests that sham acupuncture is associated with larger effects than, for example, a pharmacological placebo. This could explain why acupuncture seems as effective — or even slightly more effective — than drug prophylaxis.”

EXPERTS COMMENT

At least two clinicians who reviewed the report for Neurology Today found the results persuasive. “Acupuncture studies are difficult because the blinding is difficult,” Richard B. Lipton, MD, FAAN, the Edwin S. Lowe professor and vice chair of neurology at the Albert Einstein College of Medicine, said. He noted that even comparisons using sham procedures may not entirely blind the patient to whether he or she is receiving a real treatment in which needles are inserted in the “meridian” — the points where energy is said to flow.

“That said, the authors in their review show that acupuncture is very substantially better than usual care. I think in aggregate these data demonstrate that real acupuncture is very helpful to people with episodic migraine in terms of reducing the number of headache days.

“My longstanding practice has been to arrange acupuncture for patients who ask for it, but not to recommend it otherwise,” Dr. Lipton said. “This review is going to impact what I do. It's 22 randomized trials, and the Cochrane review is 150 pages. I think this is an important summary of the best evidence. I think it's quite positive. I want to make my patients better so the imperfect blinding doesn't matter.”

Dawn C. Buse, PhD, associate professor of neurology at Albert Einstein College of Medicine of Yeshiva University, also found the review persuasive, while noting that the mechanism by which acupuncture works is unknown and may be influenced by factors other than the procedure itself.

“This review demonstrates that acupuncture may be helpful in reducing the frequency of migraine attacks and is likely to be well tolerated when compared to pharmacologic treatment,” she said. “We do not know from this review how patients who incorporate both acupuncture and optimized pharmacologic approaches fare. However, we know from meta-analyses of combined behavioral and pharmacologic approaches to migraine management that the combination is superior to either approach alone both in initial and sustained response.”

She added: “Evidence suggests that many additional factors unrelated to acupuncture needling including expectations, beliefs, openness to experience, and the quality of the patient-provider relationship may play important roles in the beneficial effects of acupuncture for a particular patient. In addition, it is likely that patients who participate in and as a result report benefit from acupuncture are people who are interested and open to nonpharmacologic approaches. It is likely a patient who is open to nonpharmacologic approaches may also be a patient who will take a more active role in migraine management.”

Dr. Buse noted that this type of patient is likely to have better treatment outcomes, no matter what type of treatment, due to higher levels of self-efficacy and willingness to actively engage in all aspects of treatment such as following treatment recommendations for healthy lifestyle habits, exercising, managing stress and healthy sleep hygiene.

“Based upon these findings, it is reasonable to suggest that a patient who is interested and motivated to try acupuncture to manage migraine may benefit,” she told Neurology Today. “There are likely to be few if any side effects or risks to acupuncture, other than time and financial expense since acupuncture may not be covered by insurance. In addition, it may be difficult to advise a patient how to find a provider with proper training, skill, and knowledge to provide successful treatment and to know exactly what successful treatment would entail.”

The body of literature suggests that combined pharmacologic plus behavioral approaches are superior to either one alone, Dr. Buse noted. It may be therefore wise to recommend that patients who are interested in acupuncture combine it with optimized pharmacologic and behavioral treatments for the best chance of treatment outcome with lasting benefits, she said.

Dr. Lipton echoed that comment. “Acupuncture is one of many nonpharmacologic treatments for migraine,” he said. “The nonpharmacologic interventions include education, helping people identify triggers, some vitamins and herbs that are evidence-based, cognitive-behavior therapy and biofeedback. So my broad comment is that we should not restrict what is in our toolbox and consider a range of non-pharmacologic as well as pharmacologic treatments.”

But another reviewer, Deborah I. Friedman, MD, MPH, FAAN, chief of the division of headache medicine and professor of neurology & neurotherapeutics and ophthalmology at University of Texas-Southwestern in Dallas, expressed some reservations about the quality of the data. “Acupuncture is helpful in some patients with episodic migraine, particularly as an ‘add on’ treatment, but the quality of the data from clinical trials is moderate overall. There is a lot of variability in acupuncture technique amongst practitioners,” she said. “Patients who are interested in acupuncture should be referred to reputable practitioners who have had proper training.”

She added: “In general, I don't discourage it, but I rarely suggest it as an option unless the patient asks about it, or if I get the sense that they are interested in natural remedies. I tell my patients that the clinical evidence to support acupuncture treatment for migraine is not strong, with mixed results. However, it is safe and many patients find it useful, particularly those who are attracted to ‘natural’ or non-pharmacological treatments, and those who have not tolerated conventional therapies.”

Dr. Friedman said that in the program at University of Texas Southwestern Medical Center, physical therapists are trained to do dry needling. “It seems to benefit many of our patients with refractory head and neck pain,” she said. “I make it clear to my patients that this is not the same as traditional acupuncture, and encourage them to try it once to see if it helps.”

Dr. Linde noted in his comments that the problem of blinding affects the study of many treatments that are not pharmacologic in nature. “While the overall quality of a number of trials is actually quite good, one has to keep in mind that apart from sham-controlled trials acupuncture studies are usually not blind. However, this applies to almost all non-pharmacological treatments.”